| | Class 2 Recall
TITANIUM POWERPORT ISP IMPLANTED PORT WITH 6 FR CHRONOFLEX POLYURETHANE CATHETER |  |
| Date Posted |
April 29, 2010 |
| Recall Number |
Z-1525-2010 |
| Product |
PowerPort isp M.R.I Implanted Port without Suture Plugs with attachable 6F Chronoflex Polyurethane Open-ended Single -Lumen Venous Catheter, BARD Access Systems Assembled in Mexico
Indicated for patient therapies requiring repeated access to the vascular system for the infusion of medications, I.V. fluids, parenteral nutrition solutions, blood products and blood sample withdrawals. |
| Code Information |
REF#1806061
2 lots:
Lot # RETE0854 and RETG1016
|
Recalling Firm/
Manufacturer |
Bard Access Systems
605 North 5600 West
Salt Lake City, Utah 84116-3738 |
| For Additional Information Contact |
BAS Customer Service
800-290-1689
|
Reason for
Recall |
8F PowerPort stems were mixed with 6F PowerPorts and packaged.
|
| Action |
The firm, Bard Access Systems, Inc. (BAS) sent a "URGENT: Powerport isp M.R.I with 6F Chronoflex Catheter RECALL" letter dated March 18, 2010, to the customers. The letter describes the product, problem and actions to be taken by customers. The customers were instructed to immediately examine their inventory and quarantine all products subject to this recall and notify any customers they may have distributed the product to; DO NOT USE THIS PRODUCT OR FURTHER DISTRIBUTE ANY OF THE IMPLICATED LOTS; remove and return the affected lots to BAS, and complete and Fax the Reply Form and Inventory Reconciliation Form, if unable to Fax call and report information. Only unused products, in its original packaging, should be returned to BAS.
Should you have any questions or require assistance in this matter, please contact BAS Customer Service by calling our toll-free number 1-800-290-1689. |
| Quantity in Commerce |
200 units total (100 units of each lot, see code information) |
| Distribution |
Nationwide distribution: AZ, CA, DC, FL, MA, MD, NC, NE, NV, NY, PA and SC. |
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